The shortage of propofol injection products that began in the second half of 2009 has become an "ongoing and long-term problem," FDA staff reported in a teleconference with anesthesia and hospital organizations this week.
The American Association of Nurse Anesthetists, which participated in the teleconference, says that in addition to the propofol shortage, the FDA is also reporting problems with other general anesthetics and neuromuscular blocking agents that have entered the generic marketplace. "In such cases, there are a small number of manufacturers that are producing these drugs and when there is a malfunction in their manufacturer, shortages can occur," writes AANA in a message on its Web site.
Indeed, the propofol shortage began last fall when 2 makers of the generic drug, Teva and Hospira, recalled several lots due to production and potential contamination problems. Here are the latest updates from the FDA and the American Society of Health-System Pharmacists:
On March 1, Teva halted all of its propofol manufacturing and said it couldn't estimate when production would resume; the company has no propofol products available at this time.
Hospira says it's addressed the manufacturing issue that led to its October 2009 propofol recall and is estimating that it will be able to release presentations of propofol 10 mg/mL injection (currently on backorder) in mid-to-late April. Hospira is also reporting shortages of thiopental injection, an alternative to propofol.
APP continues to make weekly releases of the brand-name Diprivan as it struggles to keep up with demand. The company has also launched an approved generic propofol product that's available in 50 mL and 100 mL vials, with an expiration date of June 2010; 20 mL vials were expected to be released this week as well. To order Diprivan or generaic propofol directly from APP, call (888) 386-1300 between 8 a.m. and 7 p.m. EST.
Propoven 10mg/mL injection, a product similar to Diprivan that's manufactured at FDA-approved sites in Europe, is no longer available. APP was working with the FDA to distribute Propoven in the United States to deal with the propofol shortage, but ASHP reports those supplies have been depleted.
The FDA and AANA continue to warn facilities not to compromise the safe use of drugs — for example, by splitting single-use propofol vials into multiple doses — to deal with the shortage. The ASHP has a table outlining alternatives to propofol for procedural sedation.
Meanwhile, manufacturing delays and increased demand have also created shortages of ephedrine injection and vecuronium injection, a neuromuscular blocking agent. See the FDA's Current Drug Shortages page for updates on the availability of these anesthesia drugs. Contact the FDA's Drug Shortage Program at drugshortages@fda.hhs.gov with questions or concerns about obtaining propofol and other anesthetics in short supply.
Irene Tsikitas
